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Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension (APOLLO)

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BOL-303259-X
Timolol
BOL-303259-X
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes.
  • Participants must meet the following IOP requirements at Visit 3
  • mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye
  • IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.
  • Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.

Exclusion Criteria:

  • Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs.
  • Participants with a central corneal thickness greater than 600 μm in either eye.
  • Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
  • Participants who do not have an intact posterior capsule in either eye .
  • Participants with aphakia in either eye.
  • Participants with previous or active corneal disease in either eye.
  • Participants with current or a history of severe dry eye in either eye.
  • Participants with current or a history of optic disc hemorrhage in either eye.
  • Participants with current or a history of central/branch retinal vein or artery occlusion in either eye.
  • Participants with current or a history of macular edema in either eye.
  • Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and Participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye.
  • Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye.
  • Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening).
  • Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening).
  • Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening).

Sites / Locations

  • Bausch & Lomb Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BOL-303259-X

Timolol

Arm Description

BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).

Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).

Outcomes

Primary Outcome Measures

Mean IOP
Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).

Secondary Outcome Measures

Response Rate - IOP ≤ 18 mm Hg
Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months
Response Rate - IOP Reduction ≥ 25%
Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months

Full Information

First Posted
December 11, 2012
Last Updated
October 10, 2018
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01749904
Brief Title
Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Acronym
APOLLO
Official Title
A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 31, 2013 (Actual)
Primary Completion Date
June 2, 2015 (Actual)
Study Completion Date
September 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma, Ocular Hypertension
Keywords
Intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BOL-303259-X
Arm Type
Experimental
Arm Description
BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).
Arm Title
Timolol
Arm Type
Active Comparator
Arm Description
Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).
Intervention Type
Drug
Intervention Name(s)
BOL-303259-X
Intervention Description
Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).
Intervention Type
Drug
Intervention Name(s)
Timolol
Intervention Description
Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
Intervention Type
Drug
Intervention Name(s)
BOL-303259-X
Intervention Description
All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
Primary Outcome Measure Information:
Title
Mean IOP
Description
Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Time Frame
8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)
Secondary Outcome Measure Information:
Title
Response Rate - IOP ≤ 18 mm Hg
Description
Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months
Time Frame
8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Title
Response Rate - IOP Reduction ≥ 25%
Description
Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months
Time Frame
8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Other Pre-specified Outcome Measures:
Title
Number of Participants With Ocular and Systemic Adverse Events
Description
Following assessments through Visit 6 (Month 3), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes. Participants must meet the following IOP requirements at Visit 3 mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye IOP ≤ 36 mmHg at all 3 measurement time points in both eyes. Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye. Exclusion Criteria: Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs. Participants with a central corneal thickness greater than 600 μm in either eye. Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye. Participants who do not have an intact posterior capsule in either eye . Participants with aphakia in either eye. Participants with previous or active corneal disease in either eye. Participants with current or a history of severe dry eye in either eye. Participants with current or a history of optic disc hemorrhage in either eye. Participants with current or a history of central/branch retinal vein or artery occlusion in either eye. Participants with current or a history of macular edema in either eye. Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and Participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye. Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye. Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening). Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening). Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Vittitow
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26875002
Citation
Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J. Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study. Ophthalmology. 2016 May;123(5):965-73. doi: 10.1016/j.ophtha.2016.01.019. Epub 2016 Feb 11.
Results Reference
result
PubMed Identifier
29194198
Citation
Weinreb RN, Liebmann JM, Martin KR, Kaufman PL, Vittitow JL. Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings. J Glaucoma. 2018 Jan;27(1):7-15. doi: 10.1097/IJG.0000000000000831.
Results Reference
result

Learn more about this trial

Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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